Publication
ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European In-Vitro-Diagnostics Regulation
Joint opinion of task force on European regulatory affairs and working group accreditation and ISO/CEN standards of the European Federation of Clinical Chemistry and Laboratory Medicine
Florent J.L.A. Vanstapel, Matthias Orth, Thomas Streichert, Ettore D. Capoluongo, Wytze P. Oosterhuis, Hikmet Can Çubukçu, Francisco A. Bernabeu-Andreu, Marc Thelen, Leo H.J. Jacobs, Solveig Linko, Harjit Pal Bhattoa, Patrick M.M. Bossuyt, Pika Meško Brguljan, Guilaine Boursier, Christa M. Cobbaert, Michael Neumaier
Clinical Chemistry and Laboratory Medicine (CCLM), January 2023, De Gruyter
DOI: 10.1515/cclm-2023-0045